When I am teaching the Preventive Controls for Human Food workshop, I am often asked about Good Manufacturing Practices (GMPs). Do we still have to follow GMPs? Yes! GMPs are the foundation of a food safety system. Without GMPs or by not following GMPs, food safety cannot be achieved.
Basics done well have not changed!
A successful GMPs program requires buy in from management and commitment. In the food industry, we have seen the mindset of management change from the Quality department being a cost center to the Quality department being a necessary business expense. Quality departments have grown in personnel and budgets.
A successful GMPs program includes prerequisite programs. Some of these programs support the work you do at your facility and some of them overlap with GMPs. Prerequisite programs are procedures for the handling of ingredients and packaging from receiving to finished product at shipping, and everything in between, all with the goal of food safety. For example, your company may have a procedure for hiring and training new personnel. Prerequisite programs work hand-in-hand with GMPs and are a part of every successful company.
Let’s review where to find GMPs. GMPs have been around for ages in the food law in Part 111. Now, you will find GMPs in the FSMA rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. GMPs are a section in the Human Food rule, 21 CFR 117. In Title 21 of the Code of Federal Regulations (CFR), you will find all the rules enforced by the Food and Drug Administration; this rule is Part 117. In Part 117, there are seven sections called subparts:
Subpart A – General Provisions
Subpart B – Current Good Manufacturing Practice
Subpart C – Hazard Analysis and Risk-based Preventive Controls
Subpart D – Modified Requirements
Subpart E – Withdrawal of a Qualified Facility Exemption
Subpart F – Requirements Applying to Records That Must be Established and Maintained
Subpart G – Supply-chain Program
The FDA has dedicated one of seven subparts in the Human Food rule to GMPs; Subpart B is a big deal. Notice how GMPs are before Subpart C, which requires a facility to conduct a hazard analysis. The result of the hazard analysis is to identify hazards and then create preventive controls for each hazard. Even if a facility identifies no hazard or maybe one hazard requiring a preventive control, it doesn’t change the fact that you still need GMPs.
Even if you do not find a hazard, you still need GMPs.
The challenge in the food industry is to meet the GMPs requirement. Every facility is unique and will approach GMPs in diverse ways. The crucial step is to address GMPs to create a food manufacturing environment that results in safe food. Here is an outline of Subpart B (remember 117 means 21 CFR Part 117):
§117.20 Plant and grounds
§117.35 Sanitary operations
§117.37 Sanitary facilities and controls
§117.40 Equipment and utensils
§117.80 Processes and controls
§117.93 Warehousing and distribution
§117.95 Holding and distribution of human food by-products for use as animal food
§117.110 Defect action levels
Each facility must create programs to address the GMPs. Programs include training of personnel in food safety, sanitation procedures, and a pest control program. For optimal application, each program should have a written standard operating procedure (SOP) and means for record keeping. This includes sanitation SOPs or SSOPs. We say, “if it is not documented, it didn’t happen.” Inspectors and auditors will ask to see your documentation of GMPs.
The search for GMPs forms and checklists can be overwhelming. The ConnectFood website has the resources you need. After you sign in for free, you will find information under cGMPs. Do you have questions about GMPs? The folks at ConnectFood are here to help! Contact us.
Dr. Kathy Knutson has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.